id,agency_id,docket_id,title,document_type,subtype,posted_date,posted_year,posted_month,comment_start_date,comment_end_date,last_modified,fr_doc_num,open_for_comment,withdrawn,object_id
FDA-2024-N-3271-0002,FDA,FDA-2024-N-3271,Flamingo Pharmaceuticals Ltd.; Withdrawal of Approval of Two Abbreviated New Drug Applications,Notice,Withdrawal,2024-12-31T05:00:00Z,2024,12,2024-12-31T05:00:00Z,,2024-12-31T14:36:36Z,2024-31360,0,0,0900006486896c82
FDA-2024-N-2980-0006,FDA,FDA-2024-N-2980,"Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-On Recombinant Peptide Products;
Reopening of the Comment Period",Notice,Extension of Comment Period,2024-12-31T05:00:00Z,2024,12,2024-12-31T05:00:00Z,,2024-12-31T14:48:35Z,2024-31365,0,0,0900006486896ad4
FDA-2024-N-5830-0001,FDA,FDA-2024-N-5830,Advisory Committee; Dermatologic and Ophthalmic Drugs Advisory Committee; Renewal,Notice,Notice of Renewal,2024-12-31T05:00:00Z,2024,12,2024-12-31T05:00:00Z,,2024-12-31T14:00:03Z,2024-31363,0,0,0900006486896cc5
FDA-2016-E-4588-0006,FDA,FDA-2016-E-4588,Determination of Regulatory Review Period for Purposes of Patent Extension; XTAMPZA ER,Notice,Determinations,2024-12-30T05:00:00Z,2024,12,2024-12-30T05:00:00Z,2025-03-01T04:59:59Z,2025-02-24T02:00:23Z,2024-31023,0,0,0900006486894b77
FDA-2023-N-4597-0003,FDA,FDA-2023-N-4597,Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Shortages Data Collection,Notice,Notice of Approval,2024-12-30T05:00:00Z,2024,12,2024-12-30T05:00:00Z,,2024-12-30T16:46:09Z,2024-31025,0,0,0900006486894ecc
FDA-2024-D-5580-0001,FDA,FDA-2024-D-5580,M15 General Principles for Model- Informed Drug Development; International Council for Harmonisation; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2024-12-30T05:00:00Z,2024,12,2024-12-30T05:00:00Z,,2024-12-30T16:48:34Z,2024-31027,0,0,0900006486894ec6
FDA-2024-N-3248-0002,FDA,FDA-2024-N-3248,"Fosun Pharma USA Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications; Correction",Notice,Correction,2024-12-30T05:00:00Z,2024,12,2024-12-30T05:00:00Z,,2024-12-30T16:31:46Z,2024-31307,0,0,0900006486894fe2
FDA-2024-N-0008-0018,FDA,FDA-2024-N-0008,Request for Nominations for Individuals and Consumer Organizations for Advisory Committees,Notice,Request for Nominations,2024-12-30T05:00:00Z,2024,12,2024-12-30T05:00:00Z,,2024-12-30T15:53:25Z,2024-31270,0,0,09000064868951c3
FDA-2024-N-5702-0001,FDA,FDA-2024-N-5702,"Transfer of Regulatory Responsibility From the Center for Devices and Radiological Health to the Center for
Biologics Evaluation and Research; Medical Maggots and Medicinal Leeches",Notice,Announcement,2024-12-30T05:00:00Z,2024,12,2024-12-30T05:00:00Z,,2024-12-30T15:46:44Z,2024-31266,0,0,09000064868951c6
FDA-2024-N-0846-0003,FDA,FDA-2024-N-0846,"Agency Information Collection Activities; Announcement of Office of Management and Budget Approval;
National Agriculture and Food Defense Strategy Survey",Notice,Notice of Approval,2024-12-30T05:00:00Z,2024,12,2024-12-30T05:00:00Z,,2024-12-30T15:00:00Z,2024-31298,0,0,090000648689526c
FDA-2024-E-0302-0008,FDA,FDA-2024-E-0302,Determination of Regulatory Review Period for Purposes of Patent Extension; VEOZAH,Notice,Determinations,2024-12-30T05:00:00Z,2024,12,2024-12-30T05:00:00Z,2025-03-01T04:59:59Z,2024-12-30T17:41:51Z,2024-31269,0,0,0900006486894bff
FDA-2024-N-2149-0002,FDA,FDA-2024-N-2149,"Agency Information Collection Activities; Submission for Office of Management and Budget Review;
Comment Request; De Novo Classification Process (Evaluation of Automatic Class III Designation)",Notice,30 Day Proposed Information Collection,2024-12-30T05:00:00Z,2024,12,2024-12-30T05:00:00Z,2025-01-30T04:59:59Z,2024-12-30T16:29:16Z,2024-31014,0,0,090000648689502a
FDA-2024-E-0299-0008,FDA,FDA-2024-E-0299,Determination of Regulatory Review Period for Purposes of Patent Extension; VEOZAH,Notice,Determinations,2024-12-30T05:00:00Z,2024,12,2024-12-30T05:00:00Z,2025-03-01T04:59:59Z,2024-12-30T17:37:48Z,2024-31269,0,0,0900006486894779
FDA-2024-E-0301-0008,FDA,FDA-2024-E-0301,Determination of Regulatory Review Period for Purposes of Patent Extension; VEOZAH,Notice,Determinations,2024-12-30T05:00:00Z,2024,12,2024-12-30T05:00:00Z,2025-03-01T04:59:59Z,2024-12-30T17:40:00Z,2024-31269,0,0,0900006486894bfc
FDA-2022-D-1562-0007,FDA,FDA-2022-D-1562,E11A Pediatric Extrapolation; International Council for Harmonisation; Guidance for Industry; Availability,Notice,Notice of Availability,2024-12-30T05:00:00Z,2024,12,2024-12-30T05:00:00Z,,2024-12-30T16:34:31Z,2024-31026,0,0,0900006486894f00
FDA-2024-N-5603-0001,FDA,FDA-2024-N-5603,Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drug and Veterinary Master Files,Notice,60 Day Proposed Information Collection,2024-12-30T05:00:00Z,2024,12,2024-12-30T05:00:00Z,2025-03-01T04:59:59Z,2024-12-30T17:13:43Z,2024-31308,0,0,0900006486894dc0
FDA-2016-E-4590-0007,FDA,FDA-2016-E-4590,Determination of Regulatory Review Period for Purposes of Patent Extension; XTAMPZA ER,Notice,Determinations,2024-12-30T05:00:00Z,2024,12,2024-12-30T05:00:00Z,2025-03-01T04:59:59Z,2024-12-30T17:07:31Z,2024-31023,0,0,0900006486894b76
FDA-2024-D-5601-0001,FDA,FDA-2024-D-5601,E6(R3) Good Clinical Practice: Annex 2; International Council for Harmonisation; Draft Guidance,Notice,Notice of Availability,2024-12-30T05:00:00Z,2024,12,2024-12-30T05:00:00Z,,2024-12-30T16:08:36Z,2024-31275,0,0,0900006486895165
FDA-2024-E-0441-0006,FDA,FDA-2024-E-0441,Determination of Regulatory Review Period for Purposes of Patent Extension; ROCTAVIAN,Notice,Determinations,2024-12-30T05:00:00Z,2024,12,2024-12-30T05:00:00Z,2025-03-01T04:59:59Z,2024-12-30T17:34:49Z,2024-31276,0,0,0900006486894bfb
FDA-2024-E-0440-0006,FDA,FDA-2024-E-0440,Determination of Regulatory Review Period for Purposes of Patent Extension; ROCTAVIAN,Notice,Determinations,2024-12-30T05:00:00Z,2024,12,2024-12-30T05:00:00Z,2025-03-01T04:59:59Z,2024-12-30T17:32:54Z,2024-31276,0,0,09000064868947c5
FDA-2024-N-5720-0001,FDA,FDA-2024-N-5720,"General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting;
Establishment of Public Docket; Request for Comments—Dermal Fillers",Notice,Request for Comments,2024-12-30T05:00:00Z,2024,12,2024-12-30T05:00:00Z,2025-03-21T03:59:59Z,2025-01-03T02:01:03Z,2024-31260,0,0,09000064868952f8
FDA-2024-D-4490-0001,FDA,FDA-2024-D-4490,"Combined Food and Drug Administration and Sponsor Oncologic Drugs Advisory Committee Briefing
Document; Draft Guidance for Industry; Availability",Notice,Notice of Availability,2024-12-30T05:00:00Z,2024,12,2024-12-30T05:00:00Z,,2024-12-30T14:15:28Z,2024-31305,0,0,09000064868952fc
FDA-2023-E-3269-0005,FDA,FDA-2023-E-3269,Determination of Regulatory Review Period for Purposes of Patent Extension; NEXOBRID,Notice,Determinations,2024-12-30T05:00:00Z,2024,12,2024-12-30T05:00:00Z,2025-03-01T04:59:59Z,2024-12-30T17:20:18Z,2024-31022,0,0,0900006486894d0e
FDA-2023-D-5016-0001,FDA,FDA-2023-D-5016,"Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices; Draft Guidance
for Industry; Availability",Notice,Notice of Availability,2024-12-30T05:00:00Z,2024,12,2024-12-30T05:00:00Z,,2024-12-30T17:22:51Z,2024-31261,0,0,09000064868947c7
FDA-2024-E-0223-0006,FDA,FDA-2024-E-0223,Determination of Regulatory Review Period for Purposes of Patent Extension; OMISIRGE,Notice,Determinations,2024-12-30T05:00:00Z,2024,12,2024-12-30T05:00:00Z,2025-03-01T04:59:59Z,2024-12-30T17:17:19Z,2024-31262,0,0,0900006486894d5f
FDA-2016-E-4589-0006,FDA,FDA-2016-E-4589,Determination of Regulatory Review Period for Purposes of Patent Extension; XTAMPZA ER,Notice,Determinations,2024-12-30T05:00:00Z,2024,12,2024-12-30T05:00:00Z,2025-03-01T04:59:59Z,2024-12-30T17:05:09Z,2024-31023,0,0,0900006486894e08
FDA-2024-N-0008-0019,FDA,FDA-2024-N-0008,Request for Nominations of Individuals and Industry Organizations for the Patient Engagement Advisory Committee,Notice,Request for Nominations,2024-12-30T05:00:00Z,2024,12,2024-12-30T05:00:00Z,,2024-12-30T16:23:57Z,2024-31272,0,0,09000064868950cb
FDA-2024-N-5717-0001,FDA,FDA-2024-N-5717,Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments— Supplemental New Drug Application 218276 S–004 for FABHALTA (iptacopan) Oral Capsules in the Treatment of Adults With C3G,Notice,Request for Comments,2024-12-30T05:00:00Z,2024,12,2024-12-30T05:00:00Z,2025-02-22T04:59:59Z,2025-02-22T02:00:45Z,2024-31309,0,0,09000064868952b7
FDA-2024-N-5381-0001,FDA,FDA-2024-N-5381,Modifications to Labeling of Buprenorphine-Containing Transmucosal Products for the Treatment of Opioid Dependence,Notice,Announcement,2024-12-27T05:00:00Z,2024,12,2024-12-27T05:00:00Z,,2024-12-27T16:47:11Z,2024-30776,0,0,090000648689153c
FDA-2024-N-0009-0009,FDA,FDA-2024-N-0009,"Statement of Organization, Functions, and Delegations of Authority",Notice,General Notice,2024-12-26T05:00:00Z,2024,12,2024-12-26T05:00:00Z,,2024-12-26T14:18:34Z,2024-30334,0,0,090000648688c609
FDA-2024-N-5353-0001,FDA,FDA-2024-N-5353,Privacy Act of 1974; System of Records,Notice,System of Records,2024-12-26T05:00:00Z,2024,12,2024-12-26T05:00:00Z,2025-01-28T04:59:59Z,2024-12-26T14:43:22Z,2024-30782,0,0,090000648688c592
FDA-2024-N-4776-0006,FDA,FDA-2024-N-4776,Export Lists for Human Food: Request for Information; Extension of Comment Period,Notice,Extension of Comment Period,2024-12-26T05:00:00Z,2024,12,2024-12-26T05:00:00Z,,2024-12-26T16:08:47Z,2024-30784,0,0,090000648688bf77
FDA-2024-N-0009-0008,FDA,FDA-2024-N-0009,"Statement of Organization, Functions, and Delegations of Authority",Notice,General Notice,2024-12-23T05:00:00Z,2024,12,2024-12-23T05:00:00Z,,2024-12-23T19:55:59Z,2024-30333,0,0,09000064868864d4
FDA-2024-N-3902-0002,FDA,FDA-2024-N-3902,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution and Related Collections of Information,Notice,30 Day Proposed Information Collection,2024-12-20T05:00:00Z,2024,12,2024-12-20T05:00:00Z,2025-01-22T04:59:59Z,2024-12-20T14:17:07Z,2024-30355,0,0,09000064868815dc
FDA-2024-N-1055-0003,FDA,FDA-2024-N-1055,"Agency Information Collection Activities; Submission for Office of Management and Budget Review;
Comment Request Data To Support Social and Behavioral Research as Used by the Food and Drug Administration",Notice,30 Day Proposed Information Collection,2024-12-19T05:00:00Z,2024,12,2024-12-19T05:00:00Z,2025-01-22T04:59:59Z,2024-12-19T14:01:47Z,2024-30224,0,0,090000648687e61e
FDA-2024-N-5234-0001,FDA,FDA-2024-N-5234,"Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling:
Notification Procedures for Statements on Dietary Supplements",Notice,60 Day Proposed Information Collection,2024-12-19T05:00:00Z,2024,12,2024-12-19T05:00:00Z,2025-02-19T04:59:59Z,2024-12-19T14:06:06Z,2024-30231,0,0,090000648687e1fc
FDA-2024-N-5581-0001,FDA,FDA-2024-N-5581,"Agency Information Collection Activities; Proposed Collection; Comment Request; Food Additives Intended for Use in Animal Food, Food Additive Petitions, Investigational Food Additive Files Exemptions, and Declaration on Animal Food Labels",Notice,60 Day Proposed Information Collection,2024-12-19T05:00:00Z,2024,12,2024-12-19T05:00:00Z,2025-02-19T04:59:59Z,2025-02-13T02:00:40Z,2024-30227,0,0,090000648687e731
FDA-2024-N-5338-0001,FDA,FDA-2024-N-5338,"Agency Information Collection Activities; Proposed Collection; Comment Request; Interstate Shellfish
Dealer’s Certificate and Participation in the National Shellfish Sanitation Program",Notice,60 Day Proposed Information Collection,2024-12-19T05:00:00Z,2024,12,2024-12-19T05:00:00Z,2025-02-19T04:59:59Z,2025-02-14T02:00:11Z,2024-30228,0,0,090000648687e0d5
FDA-2024-N-3379-0002,FDA,FDA-2024-N-3379,"Agency Information Collection Activities; Submission for Office of Management and Budget Review;
Comment Request; Laboratory Accreditation for Analyses of Foods",Notice,30 Day Proposed Information Collection,2024-12-19T05:00:00Z,2024,12,2024-12-19T05:00:00Z,2025-01-22T04:59:59Z,2024-12-19T14:11:32Z,2024-30230,0,0,090000648687e1fb
FDA-2022-E-0682-0006,FDA,FDA-2022-E-0682,Determination of Regulatory Review Period for Purposes of Patent Extension; BYLVAY,Notice,Determinations,2024-12-18T05:00:00Z,2024,12,2024-12-18T05:00:00Z,2025-02-19T04:59:59Z,2025-02-20T02:00:26Z,2024-29966,0,0,090000648687b924
FDA-2024-E-0198-0007,FDA,FDA-2024-E-0198,Determination of Regulatory Review Period for Purposes of Patent Extension; SOHONOS,Notice,Determinations,2024-12-18T05:00:00Z,2024,12,2024-12-18T05:00:00Z,2025-02-19T04:59:59Z,2024-12-20T18:22:56Z,2024-29964,0,0,090000648687b925
FDA-2024-E-0196-0007,FDA,FDA-2024-E-0196,Determination of Regulatory Review Period for Purposes of Patent Extension; SOHONOS,Notice,Determinations,2024-12-18T05:00:00Z,2024,12,2024-12-18T05:00:00Z,2025-02-19T04:59:59Z,2024-12-20T18:21:56Z,2024-29964,0,0,090000648687b927
FDA-2024-E-0197-0007,FDA,FDA-2024-E-0197,Determination of Regulatory Review Period for Purposes of Patent Extension; SOHONOS,Notice,Determinations,2024-12-18T05:00:00Z,2024,12,2024-12-18T05:00:00Z,2025-02-19T04:59:59Z,2024-12-20T18:22:24Z,2024-29964,0,0,090000648687b926
FDA-2023-N-0119-0008,FDA,FDA-2023-N-0119,"Fiscal Year 2025 Generic Drug Science and Research Initiatives Workshop; Public Workshop; Request for
Comments",Notice,Request for Comments,2024-12-18T05:00:00Z,2024,12,2024-12-18T05:00:00Z,2025-07-08T03:59:59Z,2025-07-05T09:00:19Z,2024-29962,0,0,090000648687ad2f
FDA-2024-N-2844-0003,FDA,FDA-2024-N-2844,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reclassification Petitions for Medical Devices,Notice,30 Day Proposed Information Collection,2024-12-18T05:00:00Z,2024,12,2024-12-18T05:00:00Z,2025-01-18T04:59:59Z,2024-12-20T18:27:22Z,2024-29955,0,0,090000648687ad2b
FDA-2022-E-0681-0006,FDA,FDA-2022-E-0681,Determination of Regulatory Review Period for Purposes of Patent Extension; BYLVAY,Notice,Determinations,2024-12-18T05:00:00Z,2024,12,2024-12-18T05:00:00Z,2025-02-19T04:59:59Z,2024-12-20T18:16:19Z,2024-29966,0,0,090000648687b50b
FDA-2024-E-0195-0007,FDA,FDA-2024-E-0195,Determination of Regulatory Review Period for Purposes of Patent Extension; SOHONOS,Notice,Determinations,2024-12-18T05:00:00Z,2024,12,2024-12-18T05:00:00Z,2025-02-19T04:59:59Z,2024-12-20T18:21:17Z,2024-29964,0,0,090000648687af27
FDA-2022-E-0683-0006,FDA,FDA-2022-E-0683,Determination of Regulatory Review Period for Purposes of Patent Extension; BYLVAY,Notice,Determinations,2024-12-18T05:00:00Z,2024,12,2024-12-18T05:00:00Z,2025-02-19T04:59:59Z,2024-12-20T18:17:08Z,2024-29966,0,0,090000648687b21e
FDA-2023-D-4974-0031,FDA,FDA-2023-D-4974,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Advanced Manufacturing Technologies Designation Program,Notice,30 Day Proposed Information Collection,2024-12-18T05:00:00Z,2024,12,2024-12-18T05:00:00Z,2025-01-18T04:59:59Z,2024-12-18T22:12:06Z,2024-29954,0,0,090000648687b567
FDA-2024-N-5375-0001,FDA,FDA-2024-N-5375,"Revocation of Authorization of Emergency Use of B. Braun Medical’s Perfusor Space Syringe Infusion Pump System, Infusomat Space Volumetric Infusion Pump System, and Outlook ES; Availability",Notice,Announcement,2024-12-12T05:00:00Z,2024,12,,,2024-12-13T16:07:35Z,2024-29247,0,0,090000648686642c
FDA-2024-N-0008-0017,FDA,FDA-2024-N-0008,Advisory Committee; Science Board to the Food and Drug Administration;Renewal,Notice,Renewals,2024-12-12T05:00:00Z,2024,12,,,2024-12-12T14:25:11Z,2024-29231,0,0,09000064868663e5
FDA-2023-D-1716-0058,FDA,FDA-2023-D-1716,Registration and Listing of Cosmetic Product Facilities and Products; Guidance for Industry; Availability,Notice,Notice of Availability,2024-12-12T05:00:00Z,2024,12,,,2024-12-12T14:37:21Z,2024-29237,0,0,0900006486865cfe
FDA-2001-N-0431-0001,FDA,FDA-2001-N-0431,"Medical Devices; Global Harmonization Task Force; Study Group 1; Working Draft ""Medical Devices Classification;"" Availability",Notice,Notice of Data Availability,2024-12-10T05:00:00Z,2024,12,2024-12-10T05:00:00Z,2001-07-02T03:59:59Z,2024-12-12T02:01:01Z,01-12226,0,0,090000648685fcc5
FDA-2018-D-0481-0011,FDA,FDA-2018-D-0481,Standardized Format for Electronic Submission of Marketing Application Content for the Planning of Bioresearch Monitoring Inspections for Center for Drug Evaluation and Research Submissions; Guidance for Industry; Availability,Notice,Notice of Availability,2024-12-09T05:00:00Z,2024,12,,,2024-12-09T14:34:19Z,2024-28807,0,0,0900006486856197
FDA-2024-N-5331-0001,FDA,FDA-2024-N-5331,"Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee; Notice
of Meeting; Establishment of a Public Docket; Request for Comments— Extended-Release/Long-Acting Opioid Analgesic Postmarketing Requirement",Notice,Request for Comments,2024-12-09T05:00:00Z,2024,12,2024-12-09T05:00:00Z,2025-02-05T04:59:59Z,2025-04-21T15:10:18Z,2024-28811,0,0,0900006486856209
FDA-2024-D-2033-0001,FDA,FDA-2024-D-2033,Expedited Program for Serious Conditions—Accelerated Approval of Drugs and Biologics; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2024-12-06T05:00:00Z,2024,12,2024-12-06T05:00:00Z,,2025-06-08T00:55:36Z,2024-28392,0,0,090000648684b49a
FDA-2024-N-5354-0001,FDA,FDA-2024-N-5354,"Determination That Bentyl Preservative Free (Dicyclomine Hydrochloride) Injection, 10 Milligrams/Milliliters, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness",Notice,Determinations,2024-12-05T05:00:00Z,2024,12,2024-12-05T05:00:00Z,,2024-12-05T13:50:43Z,2024-28433,0,0,0900006486849ae1
FDA-2024-N-0604-0010,FDA,FDA-2024-N-0604,Yong Sheng Jiao; Denial of Hearing; Final Debarment Order,Notice,Statutory Debarment,2024-12-05T05:00:00Z,2024,12,2024-12-05T05:00:00Z,,2024-12-05T13:56:24Z,2024-28452,1,0,0900006486849adc
FDA-2022-D-2628-0035,FDA,FDA-2022-D-2628,Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions; Guidance for Industry and Food and Drug Administration Staff; Availability,Notice,Notice of Availability,2024-12-04T05:00:00Z,2024,12,,,2024-12-04T14:43:53Z,2024-28361,0,0,0900006486848770
FDA-2024-D-1334-0001,FDA,FDA-2024-D-1334,Notifying the Food and Drug Administration of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request,Notice,Notice of Availability,2024-12-04T05:00:00Z,2024,12,,,2024-12-04T14:30:12Z,2024-28230,0,0,09000064868487b9
FDA-1993-D-0285-0012,FDA,FDA-1993-D-0285,Evaluating Target Animal Safety and Effectiveness of Antibacterial New Animal Drugs for Bovine Mastitis; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2024-12-04T05:00:00Z,2024,12,,,2024-12-04T14:13:25Z,2024-28362,0,0,0900006486848834
FDA-2023-N-5653-0035,FDA,FDA-2023-N-5653,Food and Drug Administration Report and Plan on Best Practices for Guidance; Availability,Notice,Notice of Availability,2024-12-03T05:00:00Z,2024,12,2024-12-03T05:00:00Z,,2024-12-03T14:32:56Z,2024-28228,0,0,0900006486846e99
FDA-2024-N-4821-0001,FDA,FDA-2024-N-4821,"Food and Drug Administration’s Best Practices for Food and Drug Administration Communication With
Interested Parties: Draft Report for Public Comment; Availability",Notice,Notice of Availability,2024-12-03T05:00:00Z,2024,12,2024-12-03T05:00:00Z,,2024-12-03T14:28:39Z,2024-28229,0,0,0900006486846ee3
FDA-2024-N-1636-0002,FDA,FDA-2024-N-1636,Issuance of Priority Review Voucher; Rare Pediatric Disease Product; KEBILIDI (eladocagene exuparvovectneq),Notice,Announcement,2024-12-02T05:00:00Z,2024,12,2024-12-02T05:00:00Z,,2024-12-02T15:11:50Z,2024-28206,0,0,0900006486843d8e
FDA-2024-N-4085-0026,FDA,FDA-2024-N-4085,"Advancing Smoking Cessation: Food and Drug Administration and National
Institutes of Health Priorities; Public Meeting; Request for Comments; Reopening of Public Comment Period",Notice,Extension of Comment Period,2024-12-02T05:00:00Z,2024,12,,,2024-12-02T13:43:03Z,2024-28205,0,0,0900006486843e07
FDA-2024-N-5253-0001,FDA,FDA-2024-N-5253,"Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting; Establishment of a Public
Docket; Request for Comments— Biologics License Application 761393 for Condoliase Injection",Notice,Request for Comments,2024-12-02T05:00:00Z,2024,12,2024-12-02T05:00:00Z,2025-01-10T04:59:59Z,2025-01-10T02:00:46Z,2024-28210,0,0,09000064868434ce
FDA-2024-N-4731-0001,FDA,FDA-2024-N-4731,Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Detention and Banned Medical Devices,Notice,60 Day Proposed Information Collection,2024-11-29T05:00:00Z,2024,11,2024-11-29T05:00:00Z,2025-01-29T04:59:59Z,2024-11-29T15:29:20Z,2024-28044,0,0,090000648683e886
FDA-2024-N-4754-0001,FDA,FDA-2024-N-4754,Agency Information Collection Activities; Proposed Collection; Comment Request; Financial Disclosure by Clinical Investigators,Notice,60 Day Proposed Information Collection,2024-11-29T05:00:00Z,2024,11,2024-11-29T05:00:00Z,2025-01-29T04:59:59Z,2025-01-29T02:00:56Z,2024-28034,0,0,090000648683f0a1
FDA-2022-D-0084-0021,FDA,FDA-2022-D-0084,Use of Circulating Tumor Deoxyribonucleic Acid for Curative- Intent Solid Tumor Drug Development; Guidance for Industry; Availability,Notice,Notice of Availability,2024-11-29T05:00:00Z,2024,11,2024-11-29T05:00:00Z,,2024-11-29T15:07:39Z,2024-28033,0,0,090000648683f00a
FDA-2024-N-4687-0001,FDA,FDA-2024-N-4687,Agency Information Collection Activities; Proposed Collection; Comment Request; Medicated Feed Mill License Application,Notice,60 Day Proposed Information Collection,2024-11-29T05:00:00Z,2024,11,2024-11-29T05:00:00Z,2025-01-29T04:59:59Z,2024-11-29T15:20:43Z,2024-28036,0,0,090000648683efa4
FDA-2024-D-4643-0001,FDA,FDA-2024-D-4643,Assessment of Ovarian Toxicity in Premenopausal Adults During Drug Development for Oncologic Products; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2024-11-27T05:00:00Z,2024,11,2024-11-27T05:00:00Z,,2024-11-27T14:51:02Z,2024-27804,0,0,090000648683b280
FDA-2018-N-3236-0003,FDA,FDA-2018-N-3236,Advisory Committee; Oncologic Drugs Advisory Committee; Renewal,Notice,Notice of Renewal,2024-11-27T05:00:00Z,2024,11,2024-11-27T05:00:00Z,,2024-11-27T15:34:59Z,2024-27797,0,0,090000648683b12a
FDA-2024-D-4540-0001,FDA,FDA-2024-D-4540,Recommended Followup Testing for an Ames-Positive Drug (Active Ingredient) or Metabolite To Support First-in-Human Clinical Trials With Healthy Subjects; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2024-11-27T05:00:00Z,2024,11,2024-11-27T05:00:00Z,,2024-11-27T15:40:10Z,2024-27796,0,0,090000648683a82d
FDA-2024-N-2888-0010,FDA,FDA-2024-N-2888,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substantial Equivalence Reports for Tobacco Products,Notice,30 Day Proposed Information Collection,2024-11-26T05:00:00Z,2024,11,2024-11-26T05:00:00Z,2024-12-27T04:59:59Z,2024-11-26T15:28:47Z,2024-27654,0,0,0900006486837e77
FDA-2024-D-2274-0001,FDA,FDA-2024-D-2274,Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices; Guidance for Industry and Food and Drug Administration Staff; Availability,Notice,Notice of Availability,2024-11-26T05:00:00Z,2024,11,,,2024-11-26T13:54:19Z,2024-27661,0,0,0900006486837dfa
FDA-2024-N-2889-0009,FDA,FDA-2024-N-2889,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Tobacco Product Applications and Recordkeeping Requirements,Notice,30 Day Proposed Information Collection,2024-11-26T05:00:00Z,2024,11,2024-11-26T05:00:00Z,2024-12-27T04:59:59Z,2024-11-26T15:39:03Z,2024-27655,0,0,0900006486837e30
FDA-2018-N-0180-0014,FDA,FDA-2018-N-0180,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications,Notice,30 Day Proposed Information Collection,2024-11-25T05:00:00Z,2024,11,2024-11-25T05:00:00Z,2024-12-27T04:59:59Z,2024-12-11T02:00:58Z,2024-27483,0,0,0900006486833a0c
FDA-2023-D-0488-0004,FDA,FDA-2023-D-0488,"Orthopedic Non-Spinal Bone Plates, Screws, and Washers—Premarket Notification (510(k)) Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability",Notice,Notice of Availability,2024-11-22T05:00:00Z,2024,11,2024-11-22T05:00:00Z,,2024-11-22T14:35:50Z,2024-27114,0,0,090000648682e4f0
FDA-2024-N-3609-5234,FDA,FDA-2024-N-3609,Development of an Enhanced Systematic Process for the Food and Drug Administration’s Post-Market Assessment of Chemicals in Food; Public Meeting; Request for Comments; Extension of Comment Period,Notice,Extension of Comment Period,2024-11-21T05:00:00Z,2024,11,,,2024-11-22T14:23:51Z,2024-27289,0,0,090000648682b632
FDA-2016-D-2565-0035,FDA,FDA-2016-D-2565,"510(k) Third Party Review Program and Third Party Emergency Use Authorization Review; Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability",Notice,Notice of Availability,2024-11-21T05:00:00Z,2024,11,,,2024-11-21T14:14:28Z,2024-27085,0,0,090000648682c244
FDA-2024-P-2515-0004,FDA,FDA-2024-P-2515,"Determination That FORTESTA (Testosterone) Gel, 10 Milligrams/0.5 Gram Actuation, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness",Notice,Determinations,2024-11-20T05:00:00Z,2024,11,2024-11-20T05:00:00Z,,2024-11-20T14:44:01Z,2024-27103,0,0,090000648682a069
FDA-2024-N-0009-0007,FDA,FDA-2024-N-0009,"Statement of Organization, Functions, and Delegations of Authority",Notice,General Notice,2024-11-20T05:00:00Z,2024,11,2024-11-20T05:00:00Z,,2024-11-20T14:39:58Z,2024-27011,0,0,090000648682a0ad
FDA-2024-P-3699-0003,FDA,FDA-2024-P-3699,"Determination That IC-GREEN (Indocyanine Green), 25 Milligrams/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness",Notice,Determinations,2024-11-20T05:00:00Z,2024,11,2024-11-20T05:00:00Z,,2024-11-20T14:59:40Z,2024-27090,0,0,0900006486829fdf
FDA-2007-D-0369-2006,FDA,FDA-2007-D-0369,Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability,Notice,Notice of Availability,2024-11-20T05:00:00Z,2024,11,2024-11-20T05:00:00Z,,2024-11-21T19:50:01Z,2024-27048,0,0,0900006486829e19
FDA-2024-N-4604-0001,FDA,FDA-2024-N-4604,Per- and Polyfluoroalkyl Substances in Seafood; Request for Information,Notice,Requests for Information (RFI),2024-11-20T05:00:00Z,2024,11,2024-11-20T05:00:00Z,2025-02-19T04:59:59Z,2025-02-20T02:00:35Z,2024-27070,0,0,090000648682a61c
FDA-2024-P-4163-0006,FDA,FDA-2024-P-4163,"Determination That NOXAFIL (Posaconazole) Delayed-Release Tablets, 100 Grams Was Not Withdrawn From Sale for Reasons of
Safety or Effectiveness; Correction",Notice,Correction,2024-11-20T05:00:00Z,2024,11,2024-11-20T05:00:00Z,,2024-11-20T14:53:38Z,2024-27082,0,0,0900006486829fe2
FDA-2024-N-3110-0002,FDA,FDA-2024-N-3110,Miguel Angel Montalvo Villa: Final Debarment Order,Notice,General Notice,2024-11-20T05:00:00Z,2024,11,2024-11-20T05:00:00Z,,2024-11-21T19:48:38Z,2024-27093,1,0,090000648682a0b2
FDA-2022-N-0150-0013,FDA,FDA-2022-N-0150,Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID–19; Availability,Notice,Announcement,2024-11-20T05:00:00Z,2024,11,2024-11-20T05:00:00Z,,2024-11-20T14:49:41Z,2024-27094,0,0,0900006486829fe4
FDA-2024-P-3482-0003,FDA,FDA-2024-P-3482,"Determination That JESDUVROQ (daprodustat) Tablets, 1 Milligram, 2 Milligrams, 4 Milligrams, 6 Milligrams, and 8 Milligrams, Were Not Withdrawn
From Sale for Reasons of Safety or Effectiveness",Notice,Determinations,2024-11-19T05:00:00Z,2024,11,2024-11-19T05:00:00Z,,2024-11-19T15:23:17Z,2024-26915,0,0,090000648682768f
FDA-2024-N-3111-0002,FDA,FDA-2024-N-3111,Ivette Maria Portela Martinez: Final Debarment Order,Notice,Statutory Debarment,2024-11-19T05:00:00Z,2024,11,2024-11-19T05:00:00Z,,2024-11-19T13:28:57Z,2024-26912,1,0,0900006486827777
FDA-2023-E-2611-0006,FDA,FDA-2023-E-2611,Determination of Regulatory Review Period for Purposes of Patent Extension; AGILI–C,Notice,Determinations,2024-11-19T05:00:00Z,2024,11,2024-11-19T05:00:00Z,2025-01-22T04:59:59Z,2024-11-19T13:37:18Z,2024-26910,0,0,0900006486827d2d
FDA-2024-N-4860-0001,FDA,FDA-2024-N-4860,"Pfizer, Inc., et al.; Withdrawal of Approval of 26 New Drug Applications",Notice,Withdrawal,2024-11-19T05:00:00Z,2024,11,2024-11-19T05:00:00Z,,2024-11-19T15:18:07Z,2024-26913,0,0,0900006486827693
FDA-2020-P-1991-0005,FDA,FDA-2020-P-1991,"Determination That HYDROCORTONE (Hydrocortisone Sodium Phosphate) Injection, Equivalent to 50 Milligrams Base/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness",Notice,Determinations,2024-11-19T05:00:00Z,2024,11,2024-11-19T05:00:00Z,,2024-11-19T13:22:51Z,2024-26916,0,0,0900006486827825
FDA-2024-D-4311-0001,FDA,FDA-2024-D-4311,Frequently Asked Questions—Developing Potential Cellular and Gene Therapy Products; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2024-11-19T05:00:00Z,2024,11,2024-11-19T05:00:00Z,,2024-11-19T14:45:46Z,2024-26918,0,0,09000064868276db
FDA-2023-E-2610-0006,FDA,FDA-2023-E-2610,Determination of Regulatory Review Period for Purposes of Patent Extension; AGILI–C,Notice,Determinations,2024-11-19T05:00:00Z,2024,11,2024-11-19T05:00:00Z,2025-01-22T04:59:59Z,2024-11-19T13:34:39Z,2024-26910,0,0,090000648682771d
FDA-2024-N-1178-0002,FDA,FDA-2024-N-1178,Kevin Sheng Hsiang Fang: Final Debarment Order,Notice,Statutory Debarment,2024-11-19T05:00:00Z,2024,11,2024-11-19T05:00:00Z,,2024-11-19T13:18:29Z,2024-26917,1,0,0900006486827858
FDA-2021-P-0940-0004,FDA,FDA-2021-P-0940,"Determination That HYDROCORTONE (Hydrocortisone Sodium Phosphate) Injection, Equivalent to 50 Milligrams Base/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness",Notice,Determinations,2024-11-19T05:00:00Z,2024,11,2024-11-19T05:00:00Z,,2024-11-19T13:25:25Z,2024-26916,0,0,0900006486827d2c
FDA-2024-N-4467-0001,FDA,FDA-2024-N-4467,Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug User Fee Program,Notice,60 Day Proposed Information Collection,2024-11-18T05:00:00Z,2024,11,2024-11-18T05:00:00Z,2025-01-18T04:59:59Z,2024-12-05T02:00:48Z,2024-26801,0,0,090000648681f48c
FDA-2024-D-4624-0001,FDA,FDA-2024-D-4624,Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2024-11-15T05:00:00Z,2024,11,2024-11-15T05:00:00Z,,2024-11-15T14:15:24Z,2024-26682,0,0,0900006486817487
FDA-2024-N-4815-0001,FDA,FDA-2024-N-4815,Patient-Focused Drug Development: Workshop To Discuss Methodologic and Other Challenges Related to Patient Experience Data; Public Workshop; Request for Comments,Notice,Request for Comments,2024-11-14T05:00:00Z,2024,11,2024-11-14T05:00:00Z,2025-02-12T04:59:59Z,2025-02-12T02:00:33Z,2024-26399,0,0,0900006486815282